Vamorolone

(Agamree®)

Agamree®

Drug updated on 9/4/2024

Dosage FormSuspension (oral; 40 mg/mL)
Drug ClassCorticosteroids
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

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Summary
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  • Agamree (Vamorolone) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Compared to Placebo: Vamorolone significantly increased TTSTAND velocity (MD = 0.04, 95% CI = 0.02-0.07, p = 0.002), TTRW velocity (MD = 0.24, 95% CI = 0.11-0.37, p = 0.0003), and TTCLIMB velocity (MD = 0.06, 95% CI = 0.05-0.06, p < 0.00001) in patients with Duchenne muscular dystrophy (DMD).
  • Compared to Glucocorticoids: Vamorolone showed a significant increase in TTRW velocity (MD = -0.14, 95% CI = -0.26 to -0.01, p = 0.03) and height percentile for age (MD = 17.82, 95% CI = 3.89-31.75, p = 0.01) in patients with DMD.

Product Monograph / Prescribing Information

Document TitleYearSource
Agamree (vamorolone) Prescribing Information. 2023Santhera Pharmaceuticals (USA), Inc., Burlington MA

Systematic Reviews / Meta-Analyses